Approval of reimbursement of RINVOQ (upadacitinib) for the treatment of moderate to severe active UC in adults in cases of failure (poor response, loss of response, intolerance or contraindication) of conventional treatments (amino-5 salicylates, corticosteroids and immunosuppressants) with at least one TNFα inhibitor and vedolizumab.
Disapproval of reimbursement in other contexts covered by the marketing authorisation indication, i.e. adult patients exhibiting a poor response, loss of response or intolerance to conventional treatment but treatment-naive in respect of at least one TNFα inhibitor and vedolizumab
Therapeutic improvement?
No therapeutic improvement in the care pathway.
Clinical Benefit
Substantial
The Committee deems that the actual clinical benefit of RINVOQ (upadacitinib) is significant only for moderate to severe active UC in adult patients who have exhibited a poor response, loss or response or intolerance, to conventional treatments, with at least one TNFα inhibitor and vedolizumab.
Clinical Added Value
no clinical added value
Considering:
the methodological quality of the pivotal studies (controlled, randomised, double-blind, relevant choices of outcome measures including quality of life, sample size), but given that the choice of placebo is regrettable in particular for biological treatment-naive patients, and the efficacy was assessed in a heterogenous population including biological treatment-naive and non-naive patients;
the evidence of superiority of upadacitinib versus placebo, with a relevant effect size both in the induction phase and maintenance phase; the lack of evidence of an effect on referral for colectomy;
the lack of comparative data versus TNFα inhibitors in patients exhibiting a poor response to a conventional basic treatment and TNFα inhibitor-naive, and versus vedolizumab (ENTYVIO), while these comparisons were possible;
and the safety profile of upadacitinib;
the Transparency Committee deems that RINVOQ (upadacitinib) provides no clinical added value (CAV V) in the therapeutic strategy of adult ulcerative colitis.
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